scholarly journals Long-term safety and efficacy of alogliptin, a DPP-4 inhibitor, in patients with type 2 diabetes: a 3-year prospective, controlled, observational study (J-BRAND Registry)

2021 ◽  
Vol 9 (1) ◽  
pp. e001787
Author(s):  
Kohjiro Ueki ◽  
Yukio Tanizawa ◽  
Jiro Nakamura ◽  
Yuichiro Yamada ◽  
Nobuya Inagaki ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Observational Study ◽  
Real World ◽  
Safety And Efficacy ◽  
The Real ◽  
Real World Setting ◽  
Group A ◽  
Group B

IntroductionGiven an increasing use of dipeptidyl peptidase-4 (DPP-4) inhibitors to treat patients with type 2 diabetes mellitus in the real-world setting, we conducted a prospective observational study (Japan-based Clinical Research Network for Diabetes Registry: J-BRAND Registry) to elucidate the safety and efficacy profile of long-term usage of alogliptin.Research design and methodsWe registered 5969 patients from April 2012 through September 2014, who started receiving alogliptin (group A) or other classes of oral hypoglycemic agents (OHAs; group B), and were followed for 3 years at 239 sites nationwide. Safety was the primary outcome. Symptomatic hypoglycemia, pancreatitis, skin disorders of non-extrinsic origin, severe infections, and cancer were collected as major adverse events (AEs). Efficacy assessment was the secondary outcome and included changes in hemoglobin A1c (HbA1c), fasting blood glucose, fasting insulin and urinary albumin.ResultsOf the registered, 5150 (group A: 3395 and group B: 1755) and 5096 (3358 and 1738) were included for safety and efficacy analysis, respectively. Group A patients mostly (>90%) continued to use alogliptin. In group B, biguanides were the primary agents, while DPP-4 inhibitors were added in up to ~36% of patients. The overall incidence of AEs was similar between the two groups (42.7% vs 42.2%). Kaplan-Meier analysis revealed the incidence of cancer was significantly higher in group A than in group B (7.4% vs 4.8%, p=0.040), while no significant incidence difference was observed in the individual cancer. Multivariate Cox regression analysis revealed that the imbalanced patient distribution (more elderly patients in group A than in group B), but not alogliptin usage per se, contributed to cancer development. The incidence of other major AE categories was with no between-group difference. Between-group difference was not detected, either, in the incidence of microvascular and macrovascular complications. HbA1c and fasting glucose decreased significantly at the 0.5-year visit and nearly plateaued thereafter in both groups.ConclusionsAlogliptin as a representative of DPP-4 inhibitors was safe and durably efficacious when used alone or with other OHAs for patients with type 2 diabetes in the real world setting.

scholarly journals Once daily versus twice daily Linagliptin effect on glycemic levels in type 2 diabetes mellitus- an observational study

2017 ◽  
Vol 5 (10) ◽  
pp. 4403
Author(s):  
Riyaz Mohammed ◽  
Mohammed Azfar Ali
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Observational Study ◽  
Plasma Concentrations ◽  
Fixed Dose ◽  
Once Daily ◽  
Group A ◽  
Group B

Background: DPP-4 is widely distributed in endothelial cells, pancreas, uterus, liver, salivary glands, lymph node, spleen, and thymus. DPP-4 regulates glucagon-like peptide (GLP)-1, and glucose-dependent insulin tropic peptide (GIP) which leads to glucose homeostasis via enhancing insulin secretion and suppression of glucagon, which results in control of post-prandial and fasting hyperglycemia.Methods: These 40 patients who were enrolled as per the inclusion criteria of receiving metformin dosage of 2 gram per day in established type 2 diabetes mellitus patients with no comorbidities. these patients were divided randomly into two groups comprising of 20 patients each, group A received linagliptin 5 mg per day in addition to metformin 1gm twice daily whereas group B received linagliptin 5 mg per day in a fixed dose (Linagliptin + metformin) of 2.5/1000 twice daily.Results: In the present observational study, the mean age in group A was 46.7±9.4 compared to 51.65±9.9 in group B, p >0.05, mean BMI in group A was 27.8±1.1 compared to 27.28±0.93 in group B p >0.05, Mean FBS in group A was 157.9±24.1 compared to 146.2±21.8 in group B p >0.05, Mean PPBS in group A was 245.8±32.7 compared to 246.2±39.3 in group B p >0.05 and Mean HbA1c in group A was 7.67±0.58 compared to 7.6±0.5 in group B p >0.05. Group A patients were initiated on once daily linagliptin, there was a significant reduction in FBS, PPBS and HbA1c at the end of 6 months p <0.001. Similarly, Group B patients who were initiated on twice daily linagliptin also showed a significant reduction in FBS, PPBS and HbA1c at the end of 6 months p <0.001.Conclusions: The addition of linagliptin to metformin treatment was effective and well tolerated in patients with type 2 diabetes. Linagliptin add-on to metformin during the early course of treatment helps in delaying the exhaustion of pancreatic islet function. Plasma concentrations of linagliptin decline in at least a biphasic manner with a long terminal half-life (>100 hours), related to the saturable binding of linagliptin to DPP-4. The prolonged elimination phase does not contribute to the accumulation of the drug. Addition of linagliptin to metformin has shown a significant reduction in FBS, PPBS and HbA1c.

scholarly journals Effectiveness of V-Go® for Patients with Type 2 Diabetes in a Real-World Setting: A Prospective Observational Study

2019 ◽  
Vol 7 (1) ◽  
pp. 31-40 ◽  
Author(s):  
George Grunberger ◽  
Cheryl R. Rosenfeld ◽  
Bruce W. Bode ◽  
Scott D. Abbott ◽  
Carla Nikkel ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Observational Study ◽  
Real World ◽  
Prospective Observational Study ◽  
Real World Setting

Demographic and clinical profiles of type 2 diabetes mellitus patients initiating sitagliptin in the real-world setting

2017 ◽  
Vol 33 (7) ◽  
pp. 1247-1253
Author(s):  
Manjiri Pawaskar ◽  
Jinan Liu ◽  
Swapnil Rajpathak ◽  
Kristy Iglay ◽  
Samuel S. Engel ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Real World ◽  
The Real ◽  
Real World Setting ◽  
Clinical Profiles

scholarly journals Real-world GLP-1 RA therapy in type 2 diabetes: A long-term effectiveness observational study

2018 ◽  
Vol 2 (1) ◽  
pp. e00051 ◽  
Author(s):  
Santiago Tofé ◽  
Iñaki Argüelles ◽  
Elena Mena ◽  
Guillermo Serra ◽  
Mercedes Codina ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Observational Study ◽  
Real World

Long Term Effects of Liraglutide in Japanese Patients with type 2 Diabetes Among the Subgroups with Different Renal Functions: Results of 2-Year Prospective Study

Drug Research ◽  
2017 ◽  
Vol 67 (11) ◽  
pp. 640-646 ◽  
Author(s):  
Takeyuki Hiramatsu ◽  
Akiko Ozeki ◽  
Hideaki Ishikawa ◽  
Shinji Furuta
Keyword(s):  
Blood Pressure ◽  
Type 2 Diabetes ◽  
Renal Function ◽  
Japanese Patients ◽  
Left Ventricular ◽  
Long Term Effects ◽  
Group A ◽  
Group B

Abstract Aims Very few studies have ever examined the effects of long-term (>1 year) administration of liraglutide in patients with type 2 diabetes mellitus (T2DM) and renal impairment. Therefore, we conducted a 2-year study to prospectively examine the effects of liraglutide in those patients. Methods A total of 148 patients with T2DM were enrolled and treated with liraglutide (0.6 or 0.9 mg/day). 97 patients completed the 2-year study without protocol deviations. These patients were divided into 3 groups according to the baseline estimated glomerular filtration ratio (eGFR) (in mL/min/1.73 m2): group A, ≥60 (n=39); group B, ≥30 to <60 (n=38); and group C, <30 (n=20). The changes in blood and urine variables, and echocardiographic left ventricular mass index (LVMI) from baseline to 2 years were analyzed in each group. Primary outcomes were changes of the renal parameters of eGFR and albuminuria after the treatment of liraglutide. Results Blood glucose and systolic blood pressure decreased significantly after 24 months of liraglutide treatment in all groups compared with baseline (p<0.05). The eGFR increased significantly in group B (p<0.05), and remained unchanged in groups A and C. Albuminuria and LVMI decreased significantly in all 3 groups compared with baseline (p<0.05). Conclusions These findings suggest that 2 years of liraglutide treatment in Japanese patients with T2DM and impaired renal function was effective in terms of suppressing the deterioration of renal function, and reducing albuminuria. Long-term liraglutide treatment also improved glycemic control and blood pressure, and reduced left ventricular hypertrophy in this study.

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